Effect of Different Surgical Approaches of Granulomatous Mastitis

NCT06712524 | Recruiting DMC

• 1 other identifier: LLHBCH2024YN-093
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study was to prospectively investigate the effects of different surgical approaches on the recurrence rate and aesthetic outcome of patients with granulomatous mastitis. The patients were divided into traditional surgery group and plastic surgery group.

Conditions

Breast-conserving Plastic Surgery; Granulomatous Mastitis

Keywords

Granulomatous mastitis; breast conserving plastic surgery; Aesthetics scores

Outcome Measures

Primary Outcomes (1)

• Recurrence rate

  The recurrence rate of mastitis patients was compared between traditional surgery group and plastic surgery group.

  2, 3, 5 year

Secondary Outcomes (1)

• Aesthetics scores

  2, 3, 5 year

Study Arms (2)

Breast-conserving plastic surgery group

EXPERIMENTAL

Breast-conserving plastic surgery

Procedure: Breast-conserving plastic surgery

Traditional breast surgery group

ACTIVE COMPARATOR

Traditional breast surgery

Procedure: Traditional breast surgery

Interventions

Breast-conserving plastic surgery PROCEDURE

The commonly used breast conserving plastic surgery includes tennis racket, bat wing, V/J breast plasty, Grisotti and so on.

Breast-conserving plastic surgery group

Traditional breast surgery PROCEDURE

Traditional breast surgery

Traditional breast surgery group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only the subjects who meet all the following criteria may be included in this study:
• Ability to understand the study procedures and contents, and willingness to voluntarily sign the written informed consent form;
• ≤Age≤75 years old, female;
• Histologically confirmed granulomatous mastitis;
• low and moderate risk for anesthesia.

You may not qualify if:

• The subjects who meet any of the following criteria shall not be included in this study:
• Absolute and relative contraindication for surgery;
• Previous history of breast cancer or other malignancies;
• Pregnancy;
• Any serious complications which caused patients not suitable to participate this study.

Sponsors & Collaborators

• Hubei Cancer Hospital: lead

Study Sites (1)

Hubei Cancer Hospital

Wuhan, Hubei, 430060, China

RECRUITING

MeSH Terms

Conditions

Granulomatous Mastitis

Condition Hierarchy (Ancestors)

Mastitis; Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Xinhong Wu, Doctor

  Hubei Cancer Hospital

  STUDY CHAIR

Central Study Contacts

Hongmei Zheng, Doctor

CONTACT

18971624606; zhenghongmeicj@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: November 26, 2024
• First Posted: December 2, 2024
• Study Start: November 1, 2024
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 2, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)